A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients
2 other identifiers
interventional
N/A
1 country
46
Brief Summary
To determine the safety and efficacy of oral valacyclovir hydrochloride ( 256U87 ) compared to acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients with CD4 counts = or \> 100 cells/mm3.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- HIV infection with CD4 counts = or \> 100 cells/mm3.
- Documented culture of anogenital herpes simplex virus (HSV) within the last 5 years.
- History of recurrent anogenital HSV infection, with a recurrence (with or without culture) within 1 year prior to study.
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Malabsorption or vomiting that would potentially limit the retention and absorption of oral therapy.
- Concurrent Medication:
- Excluded:
- Systemic antiherpes medication.
- Interferon.
- Patients with the following prior conditions are excluded:
- History of hypersensitivity to acyclovir.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (46)
Univ of South Alabama
Mobile, Alabama, 36604, United States
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724, United States
Combat Group
Los Angeles, California, 90028, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Infectious Disease Med Group / Adult Immunology Clinic
Oakland, California, 94609, United States
UCI Med Ctr
Orange, California, 92668, United States
UCSD Med Ctr
San Diego, California, 92103, United States
San Diego Naval Hosp
San Diego, California, 921345000, United States
ViRx Inc
San Francisco, California, 94103, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110, United States
Dr Marcus Conant
San Francisco, California, 94115, United States
West Haven Veterans Administration Med Ctr
West Haven, Connecticut, 06516, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Whitman - Walker Clinic
Washington D.C., District of Columbia, 20009, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422, United States
Univ of South Florida
St. Petersburg, Florida, 33705, United States
Emory Univ School of Medicine
Atlanta, Georgia, 30303, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Northwestern Memorial Hosp
Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, 46202, United States
Univ of Iowa Hosp & Clinic
Iowa City, Iowa, 52242, United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214, United States
Univ of Maryland at Baltimore
Baltimore, Maryland, 21201, United States
St Paul Ramsey Med Ctr
Saint Paul, Minnesota, 55101, United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39216, United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108, United States
St Louis Univ
St Louis, Missouri, 63104, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Saint Vincent's Hosp and Med Ctr
New York, New York, 10011, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Univ of Rochester Med Ctr
Rochester, New York, 14642, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Univ of Pittsburgh / Graduate School of Public Health
Pittsburgh, Pennsylvania, 15261, United States
Roger Williams Med Ctr
Providence, Rhode Island, 02908, United States
Regional Med Ctr at Memphis
Memphis, Tennessee, 38103, United States
Dallas Associated Dermatologists
Dallas, Texas, 75246, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
Thomas Audetta Clinic
Houston, Texas, 77006, United States
Baylor College of Medicine / Texas Med Ctr
Houston, Texas, 77030, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
MacGregor Med Association
Houston, Texas, 77054, United States
Univ TX Med Branch / Ctr for Clinical Studies
Nassau Bay, Texas, 77058, United States
Med College of Virginia
Richmond, Virginia, 232980049, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1996-04